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Volume 7: Medicines and Cosmetics
2. The operation of medicines licensing
Annex 1 to Chapter 2: Examples of bovine materials used in medicines

Table 1: Active ingredients

Bovine By Product
Use
Source & Manufacture
Non Proprietary Medicinal Product (not the marketed trade names)
Glucagon
Polypeptide hormone - active ingredient
Pancreas. Purified using mild chemical &/or physical conditions
Glucagons
Aprotinin
Anticoagulant polypeptide - active ingredient
Various bovine tissues, mainly lung. Produced using mild chemical &/or physical conditions
Aprotinins
Heparin
Anticoagulant - active ingredient
Salts of sulphated glucosaminoglycans prepared from lungs and intestinal mucosa. Highly purified using mild chemical and physical conditions
Heparins, heparin salts (calcium and sodium), low molecular weight heparins (tinzaparin)
Catgut suture
Surgical sutures
Small intestine. The raw material is processed using harsh chemical washing and irradiation to sterilise
Surgical sutures
Calcium gluconate
Calcium supplement - drug substance
Bone (femur). Manufactured using very harsh chemical and physical conditions
Calcium gluconate tablets
Corticosteroids
Hormone/steroid treatments - active ingredients
Adrenal glands processed to produce cortisone, hydrocortisone, aldosterone. Mild purification conditions to ensure steroid activity
Various products as individual steroids or mixtures
Insulin
Hormone - active ingredient for diabetes treatment
Manufactured from pancreas. Highly processed using gentle conditions
Numerous bovine insulin
Collagen
Implants - drug substance
Processed from hide using harsh physical and chemical conditions. Highly processed
Collagen implants

Source: R Turner MCA DH01 tab 16

Table 2: Excipients and manufacturing ingredients

Bovine By Product
Use
Source and manufacture
Medicinal Products
Foetal Calf serum
Cell culture ingredient
Calf foetus. Produced using mild conditions and filter sterilisation
Vaccines, antibodies, recombinant proteins
Serum Albumin
Cell culture ingredient
Blood. Purified using mild chemical &/or physical conditions
Vaccines, antibodies, recombinant proteins
Adult/Immune Serum
Used as a supplement during cell culture
Blood. Produced using mild chemical and physical conditions
Vaccines, antibodies, recombinant proteins
Liver digest
Cell culture ingredient
Liver. Produced using harsh chemical &/or physical conditions
Vaccines, multi vitamin (liver extract)
Trypsin
Pancreatic enzyme used during manufacture
Pancreas. Purified using mild physical and chemical conditions
Vaccines
Lactalbumin hydrolysate
Hydrolysed milk protein. Cell culture ingredient
Milk. Produced using harsh chemical &/or physical conditions
Vaccines, antibodies, recombinant proteins
Hydrolysed Casein
Hydrolysed milk protein. Cell culture ingredient
Milk whey. Produced using chemical &/or physical conditions
Vaccines, antibodies, recombinant proteins
Calcium Caseinate
Cell culture ingredient
Milk whey. Produced using chemical &/or physical conditions
Vaccines, antibodies, recombinant proteins
Gelatine
Excipient in manufacture. Also used as a blood volume expander
Bones and hide. Highly processed by acid/alkaline hydrolysis - very harsh chemical and physical conditions
Various. Capsules, pastes, pastilles, tablets and suppositories. Blood volume expander
Peptone
Cell culture ingredient
Meat (skeletal and cardiac muscle). Produced using mild chemical &/or physical conditions
Vaccines, antibodies, recombinant proteins
Casein
Cell culture ingredient
Milk whey. Produced using chemical &/or physical conditions
Hormones, enzymes
Lactose
Widely used as a diluent to give bulk to powders and as a diluent in compressed tablets
Milk. Carboyhdrate manufactured from milk using relatively mild chemical &/or physical conditions
Various.
Chymotrypsin
Pancreatic enzyme used in production of medicinal products
Pancreas. Manufactured using mild conditions
Cholic and deoxycholic acids
Detergent used as manufacturing ingredients (viral inactivation)
Bile. Highly processed using harsh chemical and physical conditions
Vaccines, plasma derived medicinal products, recombinant protein products
Tryptone
Cell culture ingredient
Meat (skeletal and cardiac muscle). Produced using mild chemical &/or physical conditions
Recombinant protein medicine

Source: R Turner MCA DH01 tab 16

Table 3: Tallow derivatives

Bovine By Product
Use
Source & Manufacture
Medicinal Products
Oleic acid
Excipient in manufacture
Tallow derivative. Tallow is manufactured from bovine tissue (fat) under high temperature. Derivative production uses high temperature, pressures and concentrations of alkali. Tallow derivatives are all highly processed
Various, mainly ointments
Stearic acid and salts (magnesium/calcium)
Excipient in manufacture
Tallow derivative. Tallow is manufactured from bovine tissue (fat) under high temperature. Derivative production uses high temperature, pressures and concentrations of alkali. Tallow derivatives are all highly processed
Various as excipient/manufacturing ingredient
Sorbitan monostearate
Excipient in manufacture
Tallow derivative (detergent). Tallow is manufactured from bovine tissue (fat) under high temperature. Derivative production uses high temperature, pressures and concentrations of alkali. Tallow derivatives are all highly processed.
Various as excipient/manufacturing ingredient
Polyethylene glycol
Excipient in manufacture
Tallow derivative. Tallow is manufactured from bovine tissue (fat) under high temperature. Derivative production uses high temperature, pressures and concentrations of alkali. Tallow derivatives are all highly processed.
Various. Capsules, pastes, pastilles, tablets and suppositories
Polysorbate
Excipient in manufacture
Tallow derivative (detergent). Tallow is manufactured from bovine tissue (fat) under high temperature. Derivative production uses high temperature, pressures and concentrations of alkali. Tallow derivatives are all highly processed
Various as excipient/manufacturing ingredient
Polyoxyl stearate
Excipient in manufacture
Tallow derivative (detergent). Tallow is manufactured from bovine tissue (fat) under high temperature. Derivative production uses high temperature, pressures and concentrations of alkali. Tallow derivatives are all highly processed.
Various. Capsules, pastes, pastilles, tablets and suppositories

Source: R Turner MCA DH01 tab 16

Table 4: Examples of medical devices utilising tissues or derivatives of animal origin

Origin
Start material
Description
End use
Derivative from invertebrate source
Coral
Coral
Porites species
Bone substitute for orthopaedic fractures
Bees
Honeycomb wax
Beeswax, Apis mellifera
Product coatings
Silkworm
Cocoon filaments
Silk fibres, Bombyx mori
Sutures in surgical procedures
Microorganism
Bacterial
subtilisin enzyme, biofermentation
Enzyme cleanser for contact lenses
Microorganism
Streptococcus sp
Hyaluronic acid, biofermentation
Viscoelastic gel for ophthalmics
Derivative of animal exudate or excretory product
Sheep
Wool
Wool, blended from different sources
Range of dressings
Calf
Calf
Casein, ferment from the stomach
Stabiliser in latex production
Sheep
Wool
Lanolin, derived from sheep wool
Product coatings
Derivative of animal tissue
Cattle
Bones & hide
Gelatine, main part of connective tissue
Coatings, impregnations on cardiovascular devices
Cattle and sheep
Hard fat around kidneys
Tallow, Adeps ovillus
Aid to process of manufacture
Cattle
Bones & hide
Collagen, many structural forms
Impregnations on range of devices, dressings
Animal tissue as major component
Pigs & cattle
Heart
Valve leaflets, cardiovascular
Heart valves
Cattle
Intestine
Intestine mucosa
Sutures
Cock rooster
Combs
Hyaluronic acid
Viscoelastic gels, ophthalmics
Cattle
Heart
Cardiovascular
Percardium patches
Cattle
Tendons, ligaments
Tendons, ligaments
Ankle/knee support products
Cattle
Large bones
Bone structure, cancellous bone
Bone substitute

DH01 tab 13 p. 6

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